Senior Research and Development Engineer

AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure’s Isolator® Synergy™ Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure’s AtriClip® Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure’s Hybrid AF™ Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure’s cryoICE cryoSPHERE® probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. For more information, visit AtriCure.com or follow us on Twitter @AtriCure.We foster a culture of inclusion by embracing diverse experiences and individuals where everyone’s authentic self is welcome. We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally.Position SummaryThis position will contribute to the research and development of the next generation of AtriCure products including RF, Cryo and LAA management and potential adjacent therapies and technologies new to AtriCure. Beyond displaying knowledge of core engineering and scientific principles, this position requires excellent teamwork, communication, curiosity, and organizational skills to assist us in growing our business.The person in this position will work within a project team environment to develop novel and/or next generation medical devices used by cardiologists, electrophysiologists, and cardiac surgeons. Responsibilities will include design planning, prototype design and build, design analysis, design documentation, test method development, risk management, design verification and validation leadership, usability validation, design transfer to manufacturing, as well as interaction with surgeons and VOC gathering. Most work will be performed in the context of multi-disciplinary teams and under the direction of the engineering manager or a project manager.In addition to the above requirements, experience and knowledge of life/medical sciences, healthcare practices and procedures is preferred.Essential Functions Of The PositionAid in the design and development of novel RF/Cryo ablation devices and LAA management devices including ownership of assigned subsystems or componentsPerform analytical modeling / analysis of new technologies and design implementations in support of achieving clinical outcomesCollect, organize, and interpret design inputs including voice of customer (VOC) and voice of businessParticipate in the development of product specifications and requirements documents, ensuring traceability and alignment with user needsDesign and build prototypes using various rapid prototyping methods to test design conceptsCreate and review 3D CAD part files, assemblies, and associated drawings including interpretation of GD&T and tolerance analysis.Interface with suppliers to develop processes, optimize component design, and support manufacturability Perform structural, fatigue, and thermal analysis for complex medical device components, subassemblies, assemblies, and systems.Ability to perform geometric tolerancing analysis and provide design recommendationsProvide design feasibility recommendations based on material selection , processes, and functional requirements Use scientific and engineering principles to test device performance. Record, analyze, and interpret data using appropriate statistical tools.. Develop conclusions and clearly communicate findingsTroubleshoot new designs and/or develop reliability improvements for existing designsDevelop and validate test methods, including fixtures and protocols, for characterization, verification, and validation activitiesProvide testing, analysis, and reporting to predict and verify the human body interactions with designed devicesSupport and/or conduct Risk Analysis activities, including Fault Tree Analysis (FTA), Operator Misuse Analysis (OMA), and Failure Mode and Effects Analysis (FMEA) to ensure design related risks are identified and appropriately mitigatedConduct clinical laboratory activities related to new product development, including animal research studies and procedure developmentBe knowledgeable of surgical techniques, devices and procedures and be comfortable using them in a preclinical lab setting.Work with Key Opinion leaders to collect Voice of Customer data and develop and identify product requirements.Generate and document intellectual propertyAdditional Essential Functions Of The PositionRegular and predictable work performance Ability to work under fast-paced conditionsAbility to make decisions and use good judgmentAbility to prioritize various duties and multitask as requiredAbility to successfully work with othersAdditional duties as assignedBasic QualificationsBachelor’s degree required in Engineering or Life Sciences discipline or demonstrated equivalent combination of education, training, and experience5+ years of experience in similar role.Solid understanding of:Anatomy, physiology, and biophysicsIn-vitro and in-vivo lab activitiesMedical device design and prototypingExternal Standards, Design controls, Quality controls, Manufacturing methodsClinical procedure developmentLanguage of medicineFamiliarity with:Design Controls and FDA QSR 21 CFR Part 820 ISO 13485 and ISO14971A track record of:Creative and structured problem solvingPrioritizing tasks and producing deliverables per schedule expectationsConducting and reporting laboratory and animal research studiesCompletion of significant technical and broad tasks with limited direct supervisionDemonstrated proficiencies of communicating engineering best practicesUnderstanding of development life cycle including needs assessment, drafting product requirements, technology development, detail design & manufacturing systems development, regulatory requirements, and product verification / validationProficiency acting in integrated process/product teams, as well as coordinating and communicating customer requirementsExcellent written and oral communication skillsExperience and success working in team environmentExperience with data analysis, problem-solving, and troubleshootingExperience with International Usability Standards and the practical application of Usability EngineeringAbility to read technical specifications, blueprints, and drawingsAbility to travel 10%Preferred QualificationsBS in Biomedical or Mechanical EngineeringMS in Mechanical Engineering or Life Sciences disciplineStrong knowledge in DFM of molded, machined, and thermoformed componentsExperience with plastic joining techniques including ultrasonic/RF/laser welding and adhesive/solvent bondingPractical working experience with Geometric Dimensioning & Tolerancing (GD&T) and tolerance stack analysisAdvanced in SolidWorks 3D modeling, standard analysis tools and methodologiesExcellent demonstrated ability with data analysis, problem-solving, and troubleshootingTrack record of managing technical development tasks exhibiting comprehensive planning and thorough communicationExcellent understanding of industry regulations as it pertains to medical devicesExcellent understanding of external standards, design controls, quality controls, manufacturing methodsProven track record of generating and documenting intellectual propertyOther RequirementsAbility to regularly walk, sit, or stand as neededAbility to occasionally bend and push/pull as neededAbility to pass pre-employment drug screen and background checkAtriCure has a variety of benefits available for US based employees and their families. Examples include Medical & Dental beginning day 1 of employment, 401K plus match, 30 days of paid Parental Leave, in addition to maternity leave, for new moms and dads, Volunteer Time off, Pet Insurance, and more. Corporate-based employees also have full access to our on-site fitness center and cafeteria. To see a complete list of our benefits, please visit our careers website: https://www.atricure.com/careers-atricure/benefits. AtriCure participates in the federal E-Verify program to confirm the identity of and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here https://www.e-verify.gov/ AtriCure is an Equal Employment Opportunity/Affirmative Action employer and provides Drug Free Workplaces. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national or ethnic origin, age, protected veteran status, status as an individual with disability, sexual orientation, gender identity or any other characteristic protected by federal, state, or local law(s).